Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19 (NCT NCT04343651)
NCT ID: NCT04343651
Last Updated: 2023-01-04
Results Overview
Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) by count of patients showing improvement, no change or worsened. Note: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3. \[0=none, 1=mild, 2=moderate, and 3=severe\]. Higher scores mean a worse outcome. A negative change from baseline shows an improvement in symptom score.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
86 participants
Primary outcome timeframe
Clinical Improvement will be assessed at baseline and at EOT (day 14).
Results posted on
2023-01-04
Participant Flow
Participants were enrolled at study sites in the United States. The first participant was randomized on 30-Apr-2020. Data submitted represent analysis performed on data collected after all patients completed the Follow UP period.
126 patients were screened, 40 were screen failures.
Participant milestones
| Measure |
Placebo
Placebos: Placebo
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
700mg Leronlimab
Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
57
|
|
Overall Study
COMPLETED
|
17
|
33
|
|
Overall Study
NOT COMPLETED
|
12
|
24
|
Reasons for withdrawal
| Measure |
Placebo
Placebos: Placebo
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
700mg Leronlimab
Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Protocol Violation
|
4
|
6
|
|
Overall Study
Missing
|
3
|
9
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Did not start treatment
|
1
|
1
|
|
Overall Study
Patient did not complete visits 3-6
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19
Baseline characteristics by cohort
| Measure |
Placebo
n=28 Participants
Placebos: Placebo
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
700mg Leronlimab
n=56 Participants
Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Age, Continuous
|
55.36 years
n=93 Participants
|
54.59 years
n=4 Participants
|
54.85 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=93 Participants
|
56 participants
n=4 Participants
|
84 participants
n=27 Participants
|
|
COVID SYMPTOMS SCORE
Baseline symptom score less than or equal to 4
|
16 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
COVID SYMPTOMS SCORE
Baseline symptom score greater than 4
|
12 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Clinical Improvement will be assessed at baseline and at EOT (day 14).Population: The Modified Intent-to-Treat (mITT) population was defined as the set of subjects who received at least one dose of leronlimab (PRO 140) or placebo. This population was to be used for the analysis of efficacy parameters or measurements. At the time of this report, there were 84 subjects in the mITT population.
Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) by count of patients showing improvement, no change or worsened. Note: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3. \[0=none, 1=mild, 2=moderate, and 3=severe\]. Higher scores mean a worse outcome. A negative change from baseline shows an improvement in symptom score.
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebos: Placebo
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
700mg Leronlimab
n=56 Participants
Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
|---|---|---|
|
Mean Change From Baseline in Total Symptom Score
|
-3.4 units on a scale
Standard Deviation 3.19
|
-3.5 units on a scale
Standard Deviation 3.03
|
SECONDARY outcome
Timeframe: Time (in days) from initiation of study treatment until resolution of clinical symptoms (fever, myalgia, dyspnea and cough).Population: MITT
Defined as the time from initiation of study treatment to the resolution of clinical symptoms (fever, myalgia, dyspnea, cough). Data presented how the number of days at which a certain percentage of patients achieve resolution of symptoms, i.e., 50% of patients on placebo saw resolution of symptoms in 15 days, and 15 days for patients on leronlimab. The hazard ratio was 0.781, 95% Confidence Interval 0.43, 1.41 and the p-value was 0.4138. TTCR is defined as the duration from date of first exposure to treatment to the first occurrence of total symptom score equals 0.
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebos: Placebo
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
700mg Leronlimab
n=56 Participants
Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
|---|---|---|
|
Time to Clinical Resolution (TTCR)
25% subjects
|
5 days
|
8 days
|
|
Time to Clinical Resolution (TTCR)
50% subjects
|
15 days
|
15 days
|
|
Time to Clinical Resolution (TTCR)
75% subjects
|
15 days
|
15 days
|
SECONDARY outcome
Timeframe: From visit 2 (day 0) through day 14 (in days)Population: MITT
Number of patients requiring hospitalization
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebos: Placebo
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
700mg Leronlimab
n=56 Participants
Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
|---|---|---|
|
Incidence of Hospitalization
None
|
11 participants
|
22 participants
|
|
Incidence of Hospitalization
1 time
|
14 participants
|
33 participants
|
|
Incidence of Hospitalization
2 times
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Total duration of hospitalization between visit 2 (day 0) in days and end of treatmentPopulation: MITT
Duration of hospitalization in days
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebos: Placebo
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
700mg Leronlimab
n=56 Participants
Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
|---|---|---|
|
Duration (Days) of Hospitalization
|
2.0 days
Standard Deviation 3.19
|
2.1 days
Standard Deviation 3.83
|
SECONDARY outcome
Timeframe: Total duration of mechanical ventilation since visit 2 (day 0) (days)Population: MITT
Incidence of mechanical ventilation supply
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebos: Placebo
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
700mg Leronlimab
n=56 Participants
Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
|---|---|---|
|
Incidence of Mechanical Ventilation
None
|
27 Participants
|
55 Participants
|
|
Incidence of Mechanical Ventilation
1 Time
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Duration of mechanical ventilation since visit 2 (day 0) (daysPopulation: MITT
Duration (days) of mechanical ventilation supply
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebos: Placebo
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
700mg Leronlimab
n=56 Participants
Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
|---|---|---|
|
Duration of Mechanical Ventilation Supply
|
0.4 days
Standard Deviation 1.96
|
0.2 days
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Use of oxygen since visit 2 (day 0) to end of treatmentPopulation: MITT
Incidence of oxygen use over course of treatment
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebos: Placebo
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
700mg Leronlimab
n=56 Participants
Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
|---|---|---|
|
Incidence of Oxygen Use
None
|
22 Participants
|
47 Participants
|
|
Incidence of Oxygen Use
One time
|
5 Participants
|
6 Participants
|
|
Incidence of Oxygen Use
Two times
|
1 Participants
|
2 Participants
|
|
Incidence of Oxygen Use
Three times
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Total duration of oxygen use since visit 2 (day 0) to EOT (day 14) (days)Population: MITT
Duration of oxygen use in days
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebos: Placebo
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
700mg Leronlimab
n=56 Participants
Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
|---|---|---|
|
Duration of Oxygen Use
|
0.8 days
Standard Deviation 2.81
|
0.9 days
Standard Deviation 2.98
|
SECONDARY outcome
Timeframe: Mortality at EOT (day 14)Population: MITT
Incidence of mortality at day 14
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebos: Placebo
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
700mg Leronlimab
n=56 Participants
Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
|---|---|---|
|
Mortality at Day 14
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Date of first exposure to treatment to the first occurrence of ordinal scale equals "not hospitalized, no limitations of activities"Population: MITT
Time to return to normal activity from initiation of study treatment defined as duration from date of first exposure to treatment to the first occurrence of ordinal scale equals "not hospitalized, no limitations of activities"
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebos: Placebo
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
700mg Leronlimab
n=56 Participants
Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
|---|---|---|
|
Time to Return to Normal Activity
75th percentile pts return to normal
|
9.0 days
|
15.0 days
|
|
Time to Return to Normal Activity
25th percentile pts return to normal
|
4.0 days
|
5.0 days
|
|
Time to Return to Normal Activity
50th percentile pts return to normal
|
8.0 days
|
8.0 days
|
SECONDARY outcome
Timeframe: Baseline to Day 3, 7 and 14Population: MITT
NEWS2 is an assessment based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness) developed by the Royal College of Physicians (https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2). Respiratory rate (bpm) scores 0-3; Sp02 (on room air or suppl) scores 0-3; SpO2 (hypercapnic resp failure) scores 0-3; room air or supplemental O2 scores 0 (room) or 2 (suppl); temperature - scores 0-3; systolic BP scores 0-3; pulse (bpm) scores 0-3; consciousness - alert (score 0) vs. new onset confusion (score 3). The total possible score ranges from 0 to 20. The higher the score the greater the clinical risk. Higher scores indicate the need for escalation, medical review and possible clinical intervention and more intensive monitoring. Change shown is positive or negative from baseline, with a negative number indicating improvement (i.e., a decrease in total score).
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebos: Placebo
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
700mg Leronlimab
n=56 Participants
Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
|---|---|---|
|
Change From Baseline in National Early Warning Score 2 (NEWS2) to Day 3, 7 and 14
Change from Baseline to Day 3
|
0.0 score on a scale
Standard Deviation 0.87
|
-0.3 score on a scale
Standard Deviation 1.67
|
|
Change From Baseline in National Early Warning Score 2 (NEWS2) to Day 3, 7 and 14
Change from Baseline to Day 7
|
-0.2 score on a scale
Standard Deviation 1.27
|
-0.3 score on a scale
Standard Deviation 2.24
|
|
Change From Baseline in National Early Warning Score 2 (NEWS2) to Day 3, 7 and 14
Change from Baseline to Day 14
|
-0.2 score on a scale
Standard Deviation 1.06
|
-0.4 score on a scale
Standard Deviation 2.42
|
SECONDARY outcome
Timeframe: Mean change in percent oxygen saturation from baseline to Days 3, 7 and 14Population: MITT
Mean change in percent oxygen saturation from baseline to Days 3, 7 and 14 for patients with paired values
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebos: Placebo
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
700mg Leronlimab
n=56 Participants
Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
|---|---|---|
|
Mean Change in Percent Oxygen Saturation From Baseline to Days 3, 7 and 14
Mean change from Baseline to Day 14 of percent oxygen saturation
|
0.6 Mean change in % O2 sat
Standard Deviation 1.73
|
0.3 Mean change in % O2 sat
Standard Deviation 2.39
|
|
Mean Change in Percent Oxygen Saturation From Baseline to Days 3, 7 and 14
Mean change from Baseline to Day 3 of percent oxygen saturation
|
0.3 Mean change in % O2 sat
Standard Deviation 1.91
|
-0.1 Mean change in % O2 sat
Standard Deviation 2.0
|
|
Mean Change in Percent Oxygen Saturation From Baseline to Days 3, 7 and 14
Mean change from Baseline to Day 7 of percent oxygen saturation
|
0.4 Mean change in % O2 sat
Standard Deviation 2.08
|
0.00 Mean change in % O2 sat
Standard Deviation 2.30
|
SECONDARY outcome
Timeframe: Assessments performed Day 0 (first treatment is Visit 2, day 0), Visit 3 (3+/- 1 day after first treatment) Visit 4 (second treatment, 7+/- 1 day from V2, day7) and end of treatment (7+/- 1 day from V4, day 14)Population: MITT
A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. Lower scores mean a worse outcome.
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebos: Placebo
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
700mg Leronlimab
n=56 Participants
Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
|---|---|---|
|
Change From Baseline in the Patient's Health Status on a 7-category Ordinal Scale on Days 3, 7 and 14
Mean change from baseline at day 3
|
0.4 units on a scale
Standard Deviation 0.80
|
0.5 units on a scale
Standard Deviation 0.75
|
|
Change From Baseline in the Patient's Health Status on a 7-category Ordinal Scale on Days 3, 7 and 14
Mean change from baseline at day 7
|
1.1 units on a scale
Standard Deviation 0.78
|
0.7 units on a scale
Standard Deviation 0.99
|
|
Change From Baseline in the Patient's Health Status on a 7-category Ordinal Scale on Days 3, 7 and 14
Mean change from baseline at day 14
|
1.2 units on a scale
Standard Deviation 0.75
|
1.0 units on a scale
Standard Deviation 1.13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 14Change in size of lesion area by chest radiograph or CT - exploratory endpoint
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 3, 7, and 14Change from baseline in serum cytokine and chemokine levels at day 3, day 7 and day 14
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 3, 7, and 14Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages at day3, day 7 and day 14
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 3, 7, and 14Change from baseline in CD3+, CD4+ and CD8+ T cell count at day 3, day 7 and day 14
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 12 other events
Deaths: 0 deaths
700mg Leronlimab
Serious events: 5 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=28 participants at risk
Placebos: Placebo
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
700mg Leronlimab
n=56 participants at risk
Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
3.6%
1/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
0.00%
0/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
Cardiac disorders
Mitral Valve Incompetence
|
3.6%
1/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
0.00%
0/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.6%
1/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
0.00%
0/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
General disorders
Chest Pain
|
7.1%
2/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
0.00%
0/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
General disorders
Death
|
0.00%
0/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
1.8%
1/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
General disorders
Swelling face
|
3.6%
1/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
0.00%
0/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
Infections and infestations
Liver Abcess
|
0.00%
0/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
1.8%
1/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
Metabolism and nutrition disorders
Dehydration
|
3.6%
1/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
0.00%
0/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
Nervous system disorders
Hypoaesthesia
|
3.6%
1/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
0.00%
0/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
1.8%
1/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
1.8%
1/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
1.8%
1/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
Respiratory, thoracic and mediastinal disorders
respiratory distress
|
3.6%
1/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
0.00%
0/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.00%
0/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
1.8%
1/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
1.8%
1/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
Vascular disorders
Hypotension
|
3.6%
1/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
0.00%
0/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
1.8%
1/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
Other adverse events
| Measure |
Placebo
n=28 participants at risk
Placebos: Placebo
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
700mg Leronlimab
n=56 participants at risk
Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
|
|---|---|---|
|
General disorders
Fatigue
|
7.1%
2/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
1.8%
1/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
Investigations
C-reactive protein increased
|
3.6%
1/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
5.4%
3/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
Infections and infestations
Pneumonia
|
7.1%
2/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
0.00%
0/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
14.3%
4/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
0.00%
0/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
2/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
0.00%
0/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
|
Infections and infestations
Urinary Tract Infection
|
3.6%
1/28 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
5.4%
3/56 • Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place